Kelun-Biotech to Present Sac-TMT Phase 3 Data at ESMO 2026

Chengdu, China, September 22, 2026

Sac-TMT Phase 3 Lung Cancer Studies Selected as LBAs

The OptiTROP-Lung06 Phase 3 study will evaluate sac-TMT plus pembrolizumab compared with chemotherapy plus pembrolizumab as first-line treatment for PD-L1-negative advanced nonsquamous NSCLC. The study has been assigned LBA66 and is scheduled for an oral presentation on October 25. The same session will feature OptiTROP-Lung04, a Phase 3 study evaluating sac-TMT versus platinum-based chemotherapy in patients with EGFR-mutated NSCLC after progression on EGFR tyrosine kinase inhibitor therapy. The final overall survival analysis from OptiTROP-Lung04 has been selected as LBA67. Both presentations are scheduled for the same metastatic NSCLC session at ESMO 2026. The selection of these studies as late-breaking presentations places sac-TMT among the clinical programs receiving prominent attention at the oncology congress. Detailed results from the studies are expected to provide further information on overall survival and other clinical outcomes. While the announcement identifies the presentations and study designs, the full datasets are not included in the release and are expected to be disclosed during the ESMO presentations.

TroFuse-005 to Present Endometrial Cancer Results

Another major sac-TMT presentation will come from the TroFuse-005/ENGOT-en23/GOG-3095 Phase 3 study in patients with previously treated advanced or recurrent endometrial cancer. The study has been selected for the ESMO 2026 Presidential Symposium and assigned presentation number LBA11. The oral presentation is scheduled for October 26. In addition to the three Phase 3 late-breaking studies, other sac-TMT research will be presented, including final overall survival analysis from OptiTROP-Breast01 in previously treated locally recurrent or metastatic triple-negative breast cancer.

Additional research will examine sac-TMT in combination with pembrolizumab in urothelial carcinoma and endometrial cancer. These studies demonstrate the breadth of the development program, which is evaluating the ADC both as a monotherapy and in combination with immune checkpoint inhibition across different solid tumors.

TROP2 ADC Expands Global Oncology Development

Sac-TMT is a TROP2-directed ADC designed to deliver a topoisomerase I inhibitor payload directly to tumor cells expressing TROP2. According to Kelun-Biotech, the molecule uses a bifunctional linker and a belotecan-derived payload known as KL610023. Following binding to TROP2 and internalization by tumor cells, the payload is released intracellularly and can cause DNA damage, cell-cycle arrest and apoptosis. The company also describes a potential bystander effect, in which the membrane-permeable payload can affect neighboring tumor cells. Kelun-Biotech licensed exclusive rights to MSD in 2022 for development, manufacturing and commercialization of sac-TMT outside Greater China.

The company reports that 18 global Phase 3 studies are currently being conducted by MSD, while Kelun-Biotech has initiated nine registrational studies in China. Sac-TMT has received regulatory approvals in China across several indications, including certain triple-negative breast cancer, EGFR-mutated NSCLC and HR-positive/HER2-negative breast cancer settings. The ESMO 2026 program therefore represents an important data milestone for the global development of sac-TMT. With presentations spanning lung cancer, breast cancer, endometrial cancer and other solid tumors, the upcoming congress will provide a broader view of the clinical development of this TROP2 ADC and its potential role across multiple oncology treatment settings.

Source: Kelun-Biotech press release